Regulatory experiments and transnational networks: the governance of pharmacogenomics in Europe and the United States

Pharmacogenomics is the use of genomic science to study human variability in drug response. Proponents of pharmacogenomics suggest that it will lead to a new era of personalized medicine through a fundamental transformation in the drug discovery and development process. Uncertainty about the regulatory standards and processes for this emergent technology have been widely cited as an obstacle to more widespread and rapid adoption of pharmacogenomics. Pharmacogenomics thus presents an ideal case study of the role of regulators in the co-production of new biomedical technologies. This paper describes the attempt to create a new transnational regulatory regime for pharmacogenomics through the creation of novel regulatory experiments by a transnational network encompassing regulatory agencies, academic scientists and industry. This process has been marked by the creation of new socio-technical spaces in the regulatory regimes for pharmaceuticals - a pre-regulatory space for the sharing of data outside the regulatory decision-making process and a pre-competitive space for the sharing of data between companies. It is marked also by the expansion of a transnational regulatory space for sharing data and setting standards across jurisdictional boundaries.